"Real Space" navigation - 3D topographical imaging for spinal surgery guidance

人体脊柱为脊髓提供保护，为运动提供灵活性，并为运动提供结构支持。它也是我们身体受创伤、退化、癌症和其他疾病影响的关键部位，所有这些疾病都可能折磨我们人口中从儿童到老年患者的个体。在需要对脊柱进行硬体植入的手术中，外科医生面临着一项非常困难的任务，即在不损害患者脊髓和邻近动脉或静脉的情况下将螺钉插入脊柱。难点在于外科医生必须将螺钉深入椎体，但只能看到骨的顶部，导致高达55%的可能性错位脊柱螺钉或植入物。因此，我们的创新包括一种外科导航系统和方法，它可以提供连续的椎体表面下可视化，以准确指导医疗植入物的插入，而无需在脊柱手术中使用额外的电离辐射。我们的外科医生和工程师团队已经设计、制造并测试了一个Alpha原型手术导航系统，该系统可以提供持续的手术指导反馈。这项I期提案将允许我们的团队获得行业和外科医生驱动的数据，以创建临床前包，以吸引战略合作伙伴，继续发展这项技术，以实现商业化的手术导航系统。

The human spine provides protection for the spinal cord, flexibility for motion, and structural support for movement. It is also a key part of our body affected by trauma, degeneration, cancer and other disease processes, all of which can afflict individuals ranging from children to elderly patients in our population. In surgeries that require hardware implantation of the spine, surgeons are faced with the very difficult task of inserting screws into the spine without causing damage to the spinal cord and adjacent arteries or veins of the patient. The difficulty lies in the fact that the surgeon must place the screws deep into the vertebrae, but can only visualize the top of the bone resulting in up to a 55% chance of misplaced spinal screws or implants. Therefore, our innovation includes a system and method for surgical navigation, which can provide continuous sub-surface visualization of the vertebrae to accurately guide the insertion of medical implants without the use of additional ionizing radiation during spinal procedures. Our team of surgeons and engineers have designed, fabricated and tested an Alpha prototype surgical navigation system that provides continuous surgical guidance feedback. This Phase I proposal will allow our team to acquire industry and surgeon driven data to create a pre-clinical package to attract strategic partnerships for the continued development of this technology towards a commercially available surgical navigation system.